Date: July 2, 2015
The following new items were added to the CDRH web pages on July 1, 2015. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Enterovirus D68; Availability
- Class I Medical Device Recall: FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation
- Federal Register: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
- Updated MQSA National Statistics